Covid-19: What you need to know today

It’s December 31, the end of the year, and India may be just a day away from approving a vaccine.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) reviewed on Wednesday data submitted by Serum Institute of India and Bharat Biotech as sought by it in its last meeting. In that meeting, in response to SII’s emergency use authorisation application for Covishield (the name given by the company to the vaccine developed by AstraZeneca/Oxford that it is manufacturing here), the committee asked for more data on safety and efficacy. SEC also indicated that it would wait for an approval of the AstraZeneca/Oxford vaccine by the UK drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA). The data was submitted last week, and on Wednesday morning, MHRA approved the vaccine (the Phase 3 trials were carried out in the UK and Brazil; Indian phase 3 trials are ongoing, and it is believed that some of the interim findings from that are part of the data submitted by the company).

Bharat Biotech is also believed to have submitted some data although it isn’t clear whether this includes interim findings from its ongoing Phase 3 trials.

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SEC has said it will meet again on Friday. It’s possible that an approval for Covishield could come the same day.

This means India could start vaccinating people as early as next week if everything else is in place.

A combination of circumstances and events has made this possible, but no one could have scripted it better – to end what may well be the worst year of this millennium with an inexpensive locally made vaccine which is easy to transport and store is the best of all possible outcomes. The new year will be more about vaccines and vaccination than anything else (even the new strain, which, as expected, has surfaced in more places and people in India). As The Who sang, “Got a feeling ’21, is going to be a good year.”

The UK has said it will start vaccinating people with the AstraZeneca/Oxford shot on Monday. Phase 3 trials have shown the vaccine to be 62% effective when two full doses are administered. That compares unfavourably with the 95% efficacy shown by vaccines from Pfizer and Moderna, but over the weekend, AstraZeneca’s CEO told The Sunday Times that the company has submitted more data to the UK drugs regulator that shows that its efficacy “after two doses, is up there with everybody else”. This data is yet to be published, but 62% efficacy is not all that bad – indeed, if AstraZeneca/Oxford had been the first to declare the results of Phase 3 trials, and put out an efficacy number of 62%, the news would have been met rapturously.

Ravaged by a new mutant strain of Sars-CoV-2 – the seven-day average of daily cases in the country is nearing 40,000; the tally for December 29 was around 53,000 – the UK has taken the brave (and radical) decision of giving one shot of the two two-shot vaccines it has approved (Pfizer/BioNTech and AstraZeneca/Oxford) to as many people as possible, instead of stocking up for scheduled second shots. This could mean an increase in the time between the two shots to as much as 12 weeks, instead of the recommended four. The UK’s decision will affect the efficacy of the vaccines for sure – only detailed studies will show to what extent – but the country’s hand may have been forced by the surge in cases that has already overwhelmed its health system. India may be tempted to follow suit, but given that the seven-day average of daily cases is at a six-month low, the country would do well to stick to its plan of administering two shots of the vaccine to 300 million people in its primary priority group (the deadline to do this is June). Serum Institute expects to increase its capacity to 100 million doses a month by March and 300 million doses by July.

The challenges posed by the pandemic are not over, and 2021 will see more challenges related to what will be the world’s biggest vaccination drive, but a dashboard of vaccinations will be a welcome addition to HT’s Covid-19 database.

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